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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 6 MM CYLINDRICAL BUR ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 6 MM CYLINDRICAL BUR ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number ROB10036
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2021
Event Type  Injury  
Manufacturer Narrative
Our reference number: case-(b)(4).
 
Event Description
It was reported that when they burred the distal ap rotation holes on "off" cutting mode during a cori tka procedure, they were using a 6 mm bur and the holes were 5 mm. They forgot that they were still in the "off" mode, and went to check out checkpoints, and then the cori prompted after the femur checkpoint verified, that they were still on "off" (there was a warning that they were still in the "off" mode when they went back to recut). After verifying the checkpoints, they remembered that they were in "off " mode and they switched back to speed control. There was not significant enough bone removed in "off" mode to impact patient outcome during the procedure. No other complications were reported.
 
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Brand NameREAL INTELLIGENCE 6 MM CYLINDRICAL BUR
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11319073
MDR Text Key231583775
Report Number3010266064-2021-00098
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberROB10036
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/11/2021 Patient Sequence Number: 1
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